A Study of RO5285119 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 14 November 2016
• Main ID: NCT01418963
• Date of registration: 15/08/2011
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RO5285119 in Healthy Volunteers
• Scientific title: A Single- and Multiple Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study in Two Single-Center Study Parts to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5285119 Following Oral Administration in Healthy Subjects
• Date of first enrolment: July 2011
• Target sample size: 77
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01418963
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male adults, 18 to 45 years of age (Part 1) or healthy male or female adults,
18 to 65 years of age (Part 2)

- Body mass index (BMI) 18.0 to 30.0 kg/m2 inclusive

- Female subjects must be surgically sterile or postmenopausal

- Male subjects must use a barrier method of contraception for the duration of the
study and for the three months after the last dosing

Exclusion Criteria:

- History or presence of any significant disease or disorder

- Positive for hepatitis B. hepatitis C or HIV infection

- History of drug or alcohol abuse or suspicion of regular consumption of drugs of
abuse

- Participation in an investigational drug or device study within 3 months prior to
first dosing

- Donation of blood within 3 months prior to first dosing

- Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)

- History of hypersensitivity or allergic reactions

- Part 2: Contraindications for MRI scans



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: RO5285119

Drug: placebo

Primary Outcome(s)

Safety: Incidence of adverse events [Time Frame: up to 5 weeks]

Secondary Outcome(s)

Pharmacodynamics (neurological effects): Profile of Mood States/Bond&Lader VAS/smell test/C-SSRS [Time Frame: up to 5 weeks]

Pharmacodynamics: Functional Magnetic Resonance Imaging [Time Frame: up to 5 weeks]

Pharmacodynamics: Biomarker levels (ACTH, prolactin, cortisol, vasopressin) [Time Frame: up to 5 weeks]

Pharmacokinetics: Area under the concentration - time curve (AUC) [Time Frame: up to 5 weeks]

Food effect: Comparison of single dose pharmacokinetics (AUC) in fasted and fed state (Part 1b) [Time Frame: up to 5 weeks]

Secondary ID(s)

BP25694

Source(s) of Monetary Support

Please refer to primary and secondary sponsors